01 1FIS FABBRICA ITALIANA SINTETICI SPA
02 1FIS Fabbrica Italiana Sintetici SpA
03 1Hubei Gedian Humanwell Pharmaceutical Co., Ltd.
04 1Jubilant Pharmova Limited
05 1Lianhe Chemical Technology (Taizhou) Co., Ltd.
06 1Novartis Grimsby Ltd.
01 1Aging Life Science Co., Ltd.
02 3Novartis Korea Ltd.
03 2Samoh Pharmaceutical Co., Ltd.
01 6Oxcarbazepine
01 2China
02 1India
03 2Italy
04 1Switzerland
Registrant Name : Novartis Korea Ltd.
Registration Date : 2021-03-10
Registration Number : 20210310-209-J-869
Manufacturer Name : FIS FABBRICA ITALIANA SINTET...
Manufacturer Address : Via Massimo D'Antona, 13 - 86039 TERMOLI (CB), Italy
Registrant Name : Samoh Pharmaceutical Co., Ltd.
Registration Date : 2021-08-19
Registration Number : 20210819-209-J-1092
Manufacturer Name : FIS Fabbrica Italiana Sintet...
Manufacturer Address : Viale Milano, 26-36075 MONTECCHIO MAGGIORE (VI), Italy
Registrant Name : Samoh Pharmaceutical Co., Ltd.
Registration Date : 2023-11-06
Registration Number : 20231106-209-J-1317
Manufacturer Name : Hubei Gedian Humanwell Pharm...
Manufacturer Address : No. 199, Jianshe Avenue, Gedian Economic Development District, E-zhou City, Hubei Pro...
Registrant Name : Aging Life Science Co., Ltd.
Registration Date : 2021-10-19
Registration Number : 20211019-209-J-1123
Manufacturer Name : Jubilant Pharmova Limited
Manufacturer Address : Plot # 18,56,57&58, KIADB Industrial Area, Nanjangud - 571 302, Mysore, Karnataka, In...
Registrant Name : Novartis Korea Ltd.
Registration Date : 2022-10-11
Registration Number : 20221011-209-J-1374
Manufacturer Name : Lianhe Chemical Technology (...
Manufacturer Address : No.3, Donghai 8th Ave., Toumengang New District, Linhai, China
Registrant Name : Novartis Korea Ltd.
Registration Date : 2021-03-16
Registration Number : 20210316-209-J-626
Manufacturer Name : Novartis Grimsby Ltd.
Manufacturer Address : Pyewipe, Grimsby, NE Lincolnshire DN 31 2SR, UK, Great Britain
A Oxcarbazepine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Oxcarbazepine, including repackagers and relabelers. The FDA regulates Oxcarbazepine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Oxcarbazepine API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
click here to find a list of Oxcarbazepine manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Oxcarbazepine supplier is an individual or a company that provides Oxcarbazepine active pharmaceutical ingredient (API) or Oxcarbazepine finished formulations upon request. The Oxcarbazepine suppliers may include Oxcarbazepine API manufacturers, exporters, distributors and traders.
click here to find a list of Oxcarbazepine suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.
Pharmaceutical companies submit a Oxcarbazepine Drug Master File in Korea (Oxcarbazepine KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Oxcarbazepine. The MFDS reviews the Oxcarbazepine KDMF as part of the drug registration process and uses the information provided in the Oxcarbazepine KDMF to evaluate the safety and efficacy of the drug.
After submitting a Oxcarbazepine KDMF to the MFDS, the registered manufacturer can provide importers or distributors with the registration number without revealing confidential information to Korean business partners. Applicants seeking to register their Oxcarbazepine API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Oxcarbazepine suppliers with KDMF on PharmaCompass.
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